Code for quality management of packaging materials and containers in direct contact with drugs

Chapter I General Provisions Article 1 In order to ensure the quality of drugs and ensure the safety and convenience of drug use, this specification is formulated in accordance with the Product Quality Law of People's Republic of China (PRC) and the Standardization Law of People's Republic of China (PRC). Article 2 This Code is the basic guideline for the production and quality management of packaging materials and containers that come into direct contact with drugs, and is applicable to the whole process of packaging materials and containers that come into direct contact with drugs. Chapter II Personnel Article 3 An enterprise must be equipped with sufficient and qualified management personnel at all levels with professional knowledge, production experience and organizational ability and engineering and technical personnel suitable for producing products. The enterprise should have an organization chart, and each responsible person should list their respective responsibilities in writing, with responsibility and power. Article 4 Enterprise leaders must be familiar with the technical business of product production, have organizational leadership ability, have certain scientific and cultural knowledge, be able to organize production according to the requirements of this specification, and be fully responsible for the implementation of the specification and product quality. Business leaders responsible for production technology and quality management must have college education or equivalent, and have experience in production and quality management. Be responsible for formulating the enterprise's quality policy, determining the quality objectives, organizing the formulation of product inspection and test methods, establishing the quality system and making it run effectively. Article 5 The person in charge of the production and quality management department of an enterprise shall have secondary professional education or equivalent education, practical experience in the production and quality management of pharmaceutical packaging materials and containers, and be able to correctly judge and handle practical problems in product production and quality management. The person in charge of the production and quality management department undertakes the following responsibilities: (1) examination and approval of written procedures and other documents; (2) Monitoring of production environment; (3) Ensure the hygiene of the factory; (4) Process verification and calibration of analytical instruments; (5) training; (six) the examination and approval and supervision of contract producers; (7) Determination and supervision of storage conditions of materials and products; (8) record keeping; (9) Supervise whether the requirements of this specification are implemented; (10) Check and investigate the factors that may affect the quality.

The persons in charge of the production and quality management departments of an enterprise shall not concurrently hold positions with each other, nor shall they be held by supernumerary personnel. Article 6 The director of the production workshop of an enterprise shall have a secondary professional education or equivalent education, and have certain practical experience in production technology. Article 7 Personnel engaged in production operation and quality inspection in key positions of an enterprise shall have a high school education or above or an equivalent education. The staff of all posts should undergo professional training and assessment, and have basic theoretical knowledge and practical skills. Article 8 An enterprise shall train all its employees, and new employees shall receive basic theoretical and practical training related to these Standards, as well as post responsibility training. Enterprises must regularly assess all kinds of personnel every year. Training records and evaluations shall be filed. Chapter III Workshops Article 9 The overall layout of the production, administration, living and auxiliary areas of an enterprise shall be reasonable and equipped with sanitary facilities that meet the production requirements. The design of clean workshop shall conform to the Design Specification for Clean Workshop in Pharmaceutical Industry. Article 10 There should be enough space in the factory building to place equipment and materials, and the layout should be reasonable according to the production process and required cleanliness level. Production operations in the same factory and adjacent factories shall not interfere with each other. Products with different cleanliness grades shall not be produced in the same production area. Eleventh factories and warehouses should have measures to prevent insects, birds, rats and other animals from entering. The workshop surface (ceiling, wall and floor) of clean room and clean area should be smooth, crack-free and easy to clean. The junction of interior wall, ceiling and floor should be arc-shaped, and the surface layer should not fall off, emit or absorb dust and particles. Twelfth plant layout should be adapted to the product technology, and the flow of people and logistics should be reasonable. Piping and lighting power supply lines in the workshop shall meet relevant requirements. The lighting in the production area should meet the technological requirements. Article 13 A factory building shall reasonably set up a sanitary passage and a safe fire-fighting passage, and the fire-fighting facilities and emergency evacuation passages shall comply with the relevant provisions of the state public security fire-fighting department. Article 14 Where a workshop produces packaging materials and containers that do not need to be cleaned by a pharmaceutical factory, its cleanliness level must correspond to the cleanliness level of the workshop (filling and filling) where packaged drugs are produced, and the area should be specifically delineated and the cleanliness level should be determined according to the production technology, procedures, quality and hygiene requirements of packaging materials and container products.

The workshops that produce packaging materials and containers that need to be cleaned in pharmaceutical factories should also have anti-pollution and dust-proof measures to ensure cleanliness.

Specific requirements for different cleanliness levels are as follows:

Cleanliness level

Dust per cubic meter of living microorganisms

Quantity/m3

Ventilation rate

(Reference value)

≥ 0.5 micron

≥5 microns

100 level

≤3500

≤5

Vertical laminar flow 0.3m/s